GMK Hinge, GMK Revision
K-Number: K172347 · 2017-11-01
ApplicantMedacta International S.A.
Decision Date2017-11-01
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
GMK Hinge, GMK Revision is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2017-11-01 under approval number K172347. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GMK Hinge, GMK Revision?
GMK Hinge, GMK Revision is a medical device that received FDA 510(k) clearance on 2017-11-01. It is manufactured by Medacta International S.A.. The 510(k) number is K172347.
When was GMK Hinge, GMK Revision approved by the FDA?
GMK Hinge, GMK Revision received FDA 510(k) clearance on 2017-11-01, under approval number K172347.
What company makes GMK Hinge, GMK Revision?
GMK Hinge, GMK Revision is manufactured by Medacta International S.A..
What is the FDA product code for GMK Hinge, GMK Revision?
The FDA product code for GMK Hinge, GMK Revision is KRO.
Other Devices by Medacta International S.A.
Related Devices (Code: KRO)
K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.
K161520ELEOS Limb Salvage SystemOnkos Surgical, Inc.
K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coatingWaldemar Link GmbH & Co. KG
K190181Instruments for LINK MEGASYSTEM-C FamilyLinkBio Corp.
K191779Attune Revision LPS InsertsDepuy(Ireland)
K190100USTAR II SystemUnited Orthopedic Corporation
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.